DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE — Class II medical device recall Z-1891-2017
Terminated recall by PEROUSE MEDICAL, reported 2017-05-10, distributed in AZ, MN, TN. Complaints regarding broken blister.
| Recall number | Z-1891-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PEROUSE MEDICAL, Ivry Le Temple, France |
| Recall initiated | 2017-04-05 |
| Classified | 2017-04-28 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2021-02-01 |
| Distributed | AZ, MN, TN |
| Countries outside the US | BE |
| Quantity | 18,431 |
| Model numbers | 0185NA, 0185ND, 018SNA, 018SND, CL3030 |
Product
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Reason for recall
Complaints regarding broken blister.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1891-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.